Biologics

• Antigens- a toxin or other foreign

substance that induces an immune

response in the body, especially the

production of antibodies.

3 Categories:

1. Biologically- an antigen is a

substance that, when introduced into

the tissue of humans or other

vertebrates that causes formation of

antibodies.

a) Immunogenicity- capacity to

induce antibody formation.

b) Specificity- governed by small

chemical sites on the antigen

molecule called the antigenic

determinants.

2. Chemically- antigens are usually

protein, however, some high

molecular weight polysaccharides

are antigenic.

3. Physically- antigens must possess

a high molecular weight. A weight of

more than 10,000 daltons is

required.

Example of antigens directly

concerned in infectious disease are:

exotoxins, proteins, polysaccharides

on the cell surface and capsules of

bacteria, and the protein coat of

virus particles.

• Antibodies- Specialized cells

of the immune system which

can recognize organisms that

invade the body (such as

bacteria, viruses, and fungi).

The antibodies are then able

to set off a complex chain of

events designed to kill these

foreign invaders.

• IgA (Alpha heavy chains)- is the

predominate immunoglobulin that

found external bodily secretion (as

saliva, tears, sweat).

• IgD (Delta heavy chains)- is

primarily found on B cell surfaces

where it functions as a receptor for

antigen

• IgE ( Epsilon heavy chains)- function

in allergic reaction.

• IgM ( Mu heavy chains)- is the first

Ig to be made by the fetus and the

first Ig to be made by a virgin B

cells when it is stimulated by

antigen.

• IgG ( Gamma heavy chains)-

Most abundant serum in

immunoglobulins. IgG is the only

class of Ig that crosses the

placenta.

Immunity Definition:

immunity is the state of having

sufficient biological defenses to avoid

infection, disease, or other unwanted

biological invasion. It is the capability

of the body to resist harmful

microbes from entering it.

• Natural immunity- is the natural

resistances with which a person is born.

• Acquired immunity- Immunity obtained

either from the development of antibodies

in response to exposure to an antigen, as

from vaccination or an attack of an

infectious disease, or from the

transmission of antibodies, as from mother

to fetus through the placenta or the

injection of antiserum.

Acquired Immunity

1. Active Immunity

a) Naturally acquired active immunity -

Receive by the body in a natural manner.

b) Artificially acquired active immunity-

Receive by the body through the

administration of a vaccine or toxoid.

2. Passive Immunity- is the transfer of active

immunity, in the form of readymade

antibodies, from one individual to another.

a) Artificially acquired passive immunity - is

a short-term immunization by the

injection of antibodies, such as gamma

globulin, that are not produced by the

recipient's cells

b) Naturally acquired passive immunity-

occurs during pregnancy, in which

certain antibodies are passed from the

maternal into the fetal bloodstream.

• A substance used to stimulate the production of antibodies and provide immunity against one or several diseases, prepared from the causative agent of a disease, its product or a synthetic substitute, treated to act as an antigen without inducing the disease.

• It may contain living, attenuated or killed viruses, killed rickettsiae.

• Vaccines create immunity that protects

you from an infection sometimes

vaccines are called immunization,

needles, or shots.

• It protect you from a specific disease

that can make you very sick, disable or

even kill you.

• They boost your body’s own defense

system which is called the immune

system.

• Vaccines do not guarantee complete protection from a disease. Sometimes, this is because, the host’s immune system simply doesn’t respond adequately or at all. This may be due to a lowered immune system in general ( diabetes, steroid use, HIV infection) or because the host immune system doesn’t have A B cell capable of generating antibodies to that antigen.

The efficacy or performance of the

vaccine is dependent on a number

of factors:1. The disease itself ( for some diseases

vaccination performs better than other disease)

2. The strain of vaccine ( some vaccinations are for different strains of disease)

3. Whether on kept to time table for the vaccination.

4. Some individuals are “non-responders” to a certain vaccine.

5. Other factors such as age or genetic predisposition.

Vaccine type Vaccine of this type on US recommended

childhood (ages 0-6) immunization

Schedule1. Live attenuated Measles, mumps, rubella,

varicella (chicken pox) ,influenza (nasal spray).

2. Killed or inactivated vaccines Polio (IPV),Hepatitis A

3. Toxoid (Inactivated Form) Diptheria

4. Subunit Conjugate Hepatitis B

Non-living vaccines include the absence of

virulent, pathogens, the ability to

manufacture these vaccines to a high level

of purity, and their stability under adverse

conditions ( for example heat) which

facilitates their use in field applications.

Viral vaccines- a drug contain either

inactivated viruses, or attenuated (alive but

not capable causing disease) viruses.

Table 13-2 Recommended Immunization Schedule for Adults

Immunizing Agent Adsorbed Tetanus and Diptheria Toxoids for

Adults

Indications for use for every adult DosagePrimarily immunization: 0.5ml intramuscularly repeated once after 4-8 weeks, then once 6-12 months later booster every 10

years

Live attenuated measles virus vaccine

Unimmunized born after 1956 and recipients of un activated vaccine 1963-1967

1000 TCID502 subcutaneously

Live Rubella Virus Vaccine influenza virus vaccine

Unimmunized young women patients with Diabetes or Chronic pulmonary, cardiovascular, or renal disease, Immunocompromised patients, those in chronic care facilities, and everyone over 65 years of age.

1000 TCID Subcutaneously

Polyvalent Pneumococcal Vaccine Patients with chronic cardiac or pulmonary disease, alcoholism cirrhosis, diabetes, Hodgkinsdisease, nephrotic syndrome, renal failure, cerebrospinal fluid leaks. Immuno suppression.

0.5ml subcutaneously or intramuscularly.

Hepatitis B vaccine Medical workers and lab workers with frequent exposure to blood or blood products, intravenous drug abusers, male homosexuals, dialysis patients, recipients of clotting factors VIII or IX, Mortuary workers, residents staff of institutions for mentally retarded and immunocomprised patients.

1ml intramuscularly in deltoid muscle, repeated after 4 weeks and again 6 months after first dose.

Small pox Vaccine

• Is the living virus vaccinla (cowpox) that has been grown in the skin of a vaccinated bovine calf. It was the first vaccine for small pox invented by Edward Jenner to treat small pox disease caused by Variola major and Variola minor viruses.

Who should get small pox vaccine?

1. Anyone who is allergic to the vaccine or any of its component (streptomycin, chlortetracycline, neomycin).

2. Pregnant women.

3. Lactating women.

4. Persons with skin problems. ( esp. eczema, and atopic dermatitis)

5. People with weakened immune system such as those with received transplant.

6. People taking medications with steroids.

7. HIV Positive.

8. People recovering from the ailment cancer.

How is this Given?

• The small pox is not given with a hypodermis needle.

• It is not a “shot” like many vaccinations.

• The vaccine is given using a bifurcard needle that is dipped into the solution. The needle is then used to prick the skin a number of times in a few seconds. The vaccine usually given in the upper arm.

Side effects of Small pox Vaccine

I. Feeling usually cold.

II. Shivering.

III. Swollen painful or huder lymph glands in the neck, armpit, or groin.

Dose:

It is administered by making punctures in the skin with special needle. Revaccination is recommended at least every 10 years.

Rabies

• Is a deadly disease caused by virus that

attacks the central nervous system. The

virus is present in the saliva, spinal fluid

and brain tissue of rabid animal, human

get rabies when they are bitten by an

infected animal.

Rabies Vaccine

• Is also known as human diploid cells

rabies vaccine HDCV.

• A sterile lyophilized preparation of either

the whire virion on subvirion rabies virus.

Whire Virion- is prepared from wistar rabies

virus grown in cultures of human diploid

embryo lung tissue and inactivated with Tri-

N-Butyl phosphate and B- propiolactone.

Subvirion Vaccine• Is prepared from the Pasteur derived

pamannoore virus crown on human

diploid cell cultures developed in

Europe and inactivated with B-

Propiolactone.

Both vaccines are supplied as 10ml,

single- dose vials of lyophilized vaccines

with accompanying diluent.

Preventive Vaccination

( No Exposure)

• People whose activities bring them to

frequent contact with rabies or with

possibly rabid animals.

• International travelers who are likely

to come in contact with animals in

parts of the world where rabies is

common.

The Pre exposure Schedule for Rabies vaccine is 3 Doses given at the following time:

• Dose 1- as appropriate

• Dose 2- 7 days after 1 dose

• Dose 3- 21 days or 28 days after 1 dose.

Yellow Fever Vaccine• Used to treat yellow fever or yellow sack, black vomit. It is a

serious disease caused by the yellow fever virus called flauivirus. Fibricus causative agent. Aedes mosquito was finally proved to be the vector of the disease.

Yellow fever can cause:

a) Fever, flu

b) Jaundice

c) Liver, kidney, respiratory organ system failure

d) death

Who should be vaccinated?

• Babies under 9 months of age babies who are 6-9 months old should only be vaccinated if the risk of getting yellow fever.

• Pregnant women

• Breast feeding women

• Weakened immune system

• People who are allergic to eggs.

Dose• Usual adult dose

0.5ml subcutaneously at least 10 days before travel.

• Usual Pediatric dose

9 months 0.5ml subcutaneously at least 10 days before travel.

Influenza Vaccine

• Is a sterile aqueous suspensions

inactivated influenza virus type A and B.

It also contains a suitable preservative

and may contain an adsorbent such as

aluminum phosphate or protamine.

• Used to treat flu virus that infect our

respiratory system as nose, throat and

sometimes lungs.

2 types of influenza Vaccine (seasonal)

1. The injection ( with killed virus)

2. Nasal spray vaccine (containing live but weakened virus)

4 things you might not know about flu vaccine:

1. There are no live virus in the flu shots.

2. The composition of vaccine changes every year.

3. The flu shots is safe for pregnant women at all stages of their pregnancy.

4. Bioscl Fluwax is not recommended for children under 5 years of age.

How long is flu vaccination good for?

The flu vaccination will protect you for

only one flu season.

Does the vaccine work right away?

It takes two weeks after the vaccination

for antibodies to develop in the body and

provide protection against virus infection.

Poliomyelitis vaccine

Is an active immunizing agent used to

prevent poliomyelitis (polio). It works by

causing your body to produce its own

protection (antibodies) against the virus

that causes polio.

Polio- is a very serious infection that

causes paralysis of the muscles that

enable you to walk and breathe.

Immunization against polio is

recommended for:

1. All infants from 6 to 12 weeks of age.

2. All children.

3. All adolescents 18 years of age.

4. Adults who are greater risk of exposure to

polio virus.

Three Types of Polio Virus

Type 1 ( Brunhilde)

Most often isolated from paralytic cases.

Type 2 ( Lansing)

Concerned in sporadic disease.

Type 3 ( Leon)

Proved to be the etiologic agent in less frequent epidemics.

2 types of polio vaccine by injection

1. Polio Virus vaccine inactivated (IPV)

- Developed by Dr. Jonas Salk. It is also called “salkvaccine”. It consist of inactivated (killed) poliovirus strains of all 3 types of poliovirus types.

2. Polio Virus vaccine inactivated enhanced potency (eIPV)

Dosing form and strength

0.5ml sc/im 2 doses 1-2 months apart with 3rd dose 6 to 12 months later OR completely vaccinated adults can receive, booster dose if traveling to polio endemic areas or where the risk of exposure is high.

Polio Virus Vaccine live oral• Oral polio vaccine was developed by Albert Sabin.

• It is also called “Trivalent oral polio vaccine” or “sabinvaccine” consist of a mixture of live, attenuated (weakened) poliovirus strains of all three poliovirus types.

Doses: 2 doses not less than 8 week intervals.

Measles Vaccine

• a highly effective vaccine used against measles.

• Contains live attenuated ruboela (measles) and rubella (German measles) viruses.

• Grown on cultures of either avian embryo tissue or human diploid cells.

• The vaccine acts by stimulating the adaptive immune response and provides long term protection against the disease. The onset of the protection is slow but the effect is long lasting.

• Stored in temperature of between 2 and 8 C and have 1 year expiration date.

Measles Virus Vaccine live or rubeola Vaccine

• Prepared from attenuated virus derived from the original Edmonston B strain.

• Grown on cultures of chicken embryo tissue.

• Recommended for active immunization of children 15 moths of age is not recommended.

Prescription product: Attenuvax ®

Rubella virus vaccine live

• Recommended for active immunization against German measles for children aged 1 to puberty and for certain other individuals.

• Use infants under 1 year age is not recommended.

• Prescription Product: Meruvax II ®

Mumps vaccines

Prepared with the B – level Jeryl Lynn strain from the virus which is grown in cell cultures of chicken embryo tissue.

Provides active immunity for at least 10 years after immunization and is particularly valuable to susceptible individuals approaching puberty and to adults.

Hepatitis Vaccine

• The vaccine contains one of the viral envelope proteins, hepatitis B surface antigen (HBsAg). It is produced by yeast cells, into which the genetic code for HBsAg has been inserted.

• A course of two to three (2–3) vaccine injections is given, the second injection at least one month after the first dose and the third injection being administered six months after the first dose. The first and second dose offer complete protection. The final injection is to prolong protection against the hepatitis B virus.

Combination Virus Vaccine

• These combination vaccines are administered subcutaneously to children 15 months age or older.

• Use in infants 15 months of age is not recommended.

Rickettsial vaccines

• Cultured in chicken embryos or in monkey kidney tissue cultures in a manner similar to that for viruses.

• They cannot be grown in artificial culture media and must be subjected to the same precautions as viruses.

Bacterial Vaccines

• a preparation of killed or

attenuated bacteria used as

an active immunizing agent.

Typhoid Vaccine

• any of several preparations of Salmonella typhi

used for immunization against typhoid fever.

• Also known as Enteric vaccine because it

prevents the effect of the disease on the

intestinal tract.

• Recommended for persons who have

household contact with known typhoid carrier or

for travelers going to areas of the world where

typhoid fever is endemic.

Cholera Vaccine

• A sterile suspension of killed cholera

vibrios

( vibrio cholerae) in isotonic sodium chloride

solution or other suitable diluent.

• An active immunizing agent in the

development of immunity to the disease.

Plague vaccine a preparation of killed Yersinia pestis bacilli, administered intramuscularly as an active immunizing agent against plague.

Pertussis vaccine a preparation of killed Bordetella pertussis bacilli or of purified antigenic components thereof, used to immunize against pertussis; generally used in combination with diphtheria and tetanus toxoids (DTP or DTaP).

Pneumococcal vaccine polyvalent a preparation of purified capsular polysaccharides from the 23 serotypes of Streptococcus pneumoniae causing the majority of pneumococcal disease; used as an active immunizing agent in persons over 2 years of age, administered intramuscularly.

Haemophilus b polysaccharide vaccine (HbPV) a preparation of highly purified capsular polysaccharide derived from Haemophilus influenzae type b, which stimulates an immune response in B lymphocytes only; administered intramuscularly or subcutaneously as an immunizing agent in children ages 18 months to 5 years.